Draft Guidance

This guidance is being distributed for comment purposes only.

Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit written or electronic comments on the draft guidance within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.regulations.gov. All comments should be identified with the docket number listed in the notice of availability that publishes in the Federal Register.

For questions regarding this draft document contact the Center for Food Safety and Applied Nutrition (CFSAN) at 301-436-2371(Updated phone: 240-402-2371).

U.S. Department of Health and Human ServicesFood and Drug AdministrationCenter for Food Safety and Applied NutritionOctober 2009

Contains Nonbinding Recommendations

Draft - Not for Implementation

Table of Contents

This draft guidance, when finalized, will represent the Food and Drug Administration’s (FDA’s) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the telephone number listed on the title page of this guidance.

I. Introduction

This guidance is intended to advise the regulated industry of FDA’s view that the term “evaporated cane juice” is not the common or usual name of any type of sweetener, including dried cane syrup, and to assist manufacturers in appropriately labeling products that contain sweeteners derived from sugar cane syrup.

FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.

II. Background

Over the past few years the term “evaporated cane juice” has started to appear as an ingredient on food labels, most commonly to declare the presence of sweeteners derived from sugar cane syrup. However, FDA’s current policy is that sweeteners derived from sugar cane syrup should not be declared as “evaporated cane juice” because that term falsely suggests that the sweeteners are juice (Refs. 1, 2, 3).

“Juice” is defined by 21 CFR 120.1(a) as “the aqueous liquid expressed or extracted from one or more fruits or vegetables, purees of the edible portions of one or more fruits or vegetables, or any concentrates of such liquid or puree.” Although FDA does not dispute that sugar cane is a member of the vegetable kingdom in the broad sense of classifying an article as “animal,” “vegetable,” or “mineral,” the agency considers the term “vegetable” in the context of the juice definition to refer more narrowly to edible plant parts that consumers are accustomed to eating as vegetables in their diet. Sugar cane is not a vegetable in this sense. While consumers can purchase pieces of sugar cane, consumers do not eat sugar cane as a “vegetable” but instead use it as a source of sugar by chewing on the cane or its fibers or by placing the cane in a beverage to sweeten it. There are other plant juices used for human food that similarly are not “vegetable juice” or “fruit juice” for purposes of the juice definition; e.g., maple syrup and sorghum syrup. In summary, FDA’s view is that the juice or extract of sugar cane is not the juice of a plant that consumers are accustomed to eating as a vegetable in their diet and is not, therefore, “juice” as contemplated by the regulation defining that term (Refs. 1, 3).

As provided in 21 CFR 101.4(a)(1), “Ingredients required to be declared on the label or labeling of a food . . . shall be listed by common or usual name . . . .” The common or usual name for an ingredient is the name established by common usage or by regulation (21 CFR 102.5(d)). The common or usual name must accurately describe the basic nature of the food or its characterizing properties or ingredients, and may not be “confusingly similar to the name of any other food that is not reasonably encompassed within the same name” (21 CFR 102.5(a)).

Sugar cane products exist in many different forms, ranging from raw sugars and syrups to refined sugar and molasses. These products are differentiated by their moisture, molasses, and sucrose content as well as by crystal size and any special treatments (e.g., treatment with sulfur). Sugar cane products with common or usual names defined by regulation are sugar (21 CFR 101.4(b)(20)) and cane sirup (alternatively spelled “syrup”) (21 CFR 168.130). Other sugar cane products have common or usual names established by common usage (e.g., molasses, raw sugar, brown sugar, turbinado sugar, muscovado sugar, and demerara sugar).(2)

Because “evaporated cane juice” and other sweeteners derived from sugar cane syrup are not “juice” as defined in 21 CFR 120.1, such ingredients should not be included in the percentage juice declaration mandated by 21 CFR 101.30. Section 101.30 requires the percentage of fruit or vegetable juice in beverages purporting to contain such ingredients to be declared on the label of the beverage. FDA has criminally prosecuted manufacturers and has seized sweetened diluted juice products that were misrepresented for sale as 100% fruit juice. These beverages, which were formulated with water, sugars from cane or corn, artificial colors and flavors, and other ingredients that were not listed in the ingredient statement, misled consumers into believing that they were purchasing a 100% juice product. The products were therefore misbranded under section 403(a)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. 343(a)(1)), as well as adulterated under section 402(b) of the Act (21 U.S.C. 342(b)), because sugars, water, and other ingredients were substituted for juice. For example, in the 1990s, FDA successfully prosecuted Flavor Fresh Foods, Inc. and Peninsular Products Company,(3) Bodine’s Inc.,(4) and Sun Up Foods., Inc.(5) for misrepresenting mixtures of water, sugar, and reconstituted apple or orange juice as 100% juice.

III. Discussion

The intent of this draft guidance is to advise the regulated industry of FDA’s view that the term “evaporated cane juice” is not the common or usual name of any type of sweetener, including dried cane syrup. Because cane syrup has a standard of identity defined by regulation in 21 CFR 168.130, the common or usual name for the solid or dried form of cane syrup is “dried cane syrup."

Sweeteners derived from sugar cane syrup should not be listed in the ingredient declaration by names which suggest that the ingredients are juice, such as “evaporated cane juice.” FDA considers such representations to be false and misleading under section 403(a)(1) of the Act (21 U.S.C. 343(a)(1)) because they fail to reveal the basic nature of the food and its characterizing properties (i.e., that the ingredients are sugars or syrups) as required by 21 CFR 102.5. Furthermore, sweeteners derived from sugar cane syrup are not juice and should not be included in the percentage juice declaration on the labels of beverages that are represented to contain fruit or vegetable juice (see 21 CFR 101.30).

IV. References

We have placed the following references on display in the Division of Dockets Management, Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. You may see them at that location between 9 a.m. and 4 p.m., Monday through Friday.

(1) This draft guidance has been prepared by the Office of Nutrition, Labeling, and Dietary Supplements in the Center for Food Safety and Applied Nutrition at the U.S. Food and Drug Administration.

(2) In developing this draft guidance, FDA reviewed the Codex Alimentarius Commission’s (Codex’s) Standard for Sugars, Codex Stan. 212-1999, which provides standards for certain sugars intended for human consumption without further processing, to determine whether Codex had established a standard for “dried cane syrup” or “evaporated cane juice.” However, the Codex Standard for Sugars contains no standard for any sweetener derived from cane syrup as defined by 21 CFR 168.130.